Health Canada approves tirzepatide for chronic weight management in adults

Eli Lilly has received Health Canada approval to market tirzepatide subcutaneous injection (Zepbound KwikPen) for chronic weight management in adults. It is indicated for once-weekly administration for chronic weight management, including weight loss and weight maintenance, as an adjunct to a reduced-calorie diet and increased physical activity.1 Zepbound is intended for adults with an initial body mass index (BMI) of ≥ 30 kg/m2 (obesity), or for adults 27 kg/m2 to < 30 kg/m2 (overweight) with at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, prediabetes, type 2 diabetes, obstructive sleep apnea, cardiovascular disease). The safety and efficacy of tirzepatide have not been established when used in combination with other products intended for weight management, including prescription or over-the-counter drugs and herbal preparations.1Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. It selectively binds to and activates GIP and GLP-1 receptors. This activates neurons in brain regions involved in regulation of appetite and food intake. Tirzepatide decreases calorie intake and appetite by increasing feelings of satiety and fullness, and by decreasing feelings of hunger. It reduces food cravings and preferences for high-sugar and high-fat foods. Tirzepatide also binds to and activates GIP receptors in human adipocytes, to regulate glucose uptake and modulate lipid uptake, lipolysis and fat utilization.1 Zepbound KwikPen will be marketed in the following strengths: 2.5 mg/0.6 mL, 5 mg/0.6 mL, 7.5 mg/0.6 mL, 10 mg/0.6 mL, 12.5 mg/0.6 mL and 15 mg/0.6 mL as a solution in multidose (2.4 mL) prefilled pens for subcutaneous (SC) use.1The recommended starting dosage is 2.5 mg SC once weekly. After four weeks, the dosage is increased to 5 mg SC once weekly. If additional weight management is needed, the dosage can be increased in 2.5 mg increments after at least four weeks on the current dose. Recommended maintenance dosages in adults are 5 mg, 10 mg or 15 mg SC once weekly. The maximum recommended dosage is 15 mg SC once weekly. No dose adjustment is required in patients with renal or hepatic impairment.1Once-weekly Zepbound can be administered at any time of day, with or without meals. It should be injected SC into the abdomen, thigh or upper arm. Injection sites should be rotated with each dose. The day of weekly administration can be changed, if needed, as long as the time between the two doses is at least three days. Patients and caregivers can be trained on proper injection technique.1Gastrointestinal disorders, including nausea, diarrhea, constipation and vomiting, are the most common adverse effects of tirzepatide for chronic weight management. These reactions are generally mild or moderate in severity.1 More serious potential adverse effects include risk of thyroid C-cell tumours, gastrointestinal adverse reactions, malnutrition, acute kidney injury, acute gallbladder disease, acute pancreatitis, hypersensitivity reactions, hypoglycemia with concomitant use of insulin secretagogues or insulin in patients with type 2 diabetes, diabetic retinopathy complications in patients with type 2 diabetes, suicidal ideation and behaviour, and aspiration during general anesthesia or deep sedation.1In terms of drug interactions, tirzepatide delays gastric emptying. This could affect the absorption of concomitantly administered oral medications (e.g., oral contraceptives); advise patients using oral hormonal contraceptives to switch to a nonoral contraceptive method, or add a barrier method of contraception for four weeks after tirzepatide initiation and for four weeks after each dose escalation. Patients with type 2 diabetes receiving tirzepatide for weight management in combination with an insulin secretagogue (e.g., a sulfonylurea) or insulin may have an increased risk of hypoglycemia; the risk may be lowered by reducing the dose of the insulin secretagogue or insulin.1Zepbound KwikPens should be stored in a refrigerator (2°C–8°C) and protected from light. If needed, a multidose pen can be stored unrefrigerated at temperatures not exceeding 30°C for up to 30 days. Patients will use one Zepbound KwikPen per month, as each pen delivers four doses of tirzepatide.1Tirzepatide (brand name Mounjaro) was originally approved in Canada in November 2022 for treatment of adults with type 2 diabetes.2References:Eli Lilly Canada Inc. Zepbound (tirzepatide injection) product monograph. Toronto, ON; May 13, 2025. (accessed June 12, 2025).Eli Lilly Canada Inc. Mounjaro (tirzepatide injection) product monograph. Toronto, ON; November 23, 2022. (accessed June 12, 2025).

Health Canada approves tirzepatide for chronic weight management in adults

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